# Fluid Therapy and Stent Management in Nephrolithiasis, USDRN extension

> **NIH NIH U01** · UT SOUTHWESTERN MEDICAL CENTER · 2022 · $655,872

## Abstract

Project Summary:
Urinary Stone Disease (USD) is an increasingly prevalent and highly recurrent condition associated
with major morbidity at a rising cost to society. Thus, improved management can significantly reduce
its health burden. Increasing fluid intake is recommended to all USD patients. However, knowledge
gaps persist regarding the impact of fluid therapy in preventing USD recurrence including effectiveness
of strategies to achieve and maintain a high urine volume, and whether such strategies reduce USD
recurrence. The Prevention of Urinary Stones with Hydration (PUSH) study is a randomized clinical trial
investigating the impact of increased fluid intake and increased urine output on the recurrence rate of
USD in adults and children. In this study 1,642 participants will be randomized to a control or
intervention arm. Participants in both arms receive a “smart water bottle”. The intervention arm involves
an additional program of behavioral interventions, including financial incentives, structured problem
solving, and low touch interventions designed to improve adherence to a prescribed fluid intake
regimen. The primary endpoint is occurrence of a stone event during a two-year observation period.
The PUSH study is in its third year, and due to multiple challenges to recruitment of study participants,
follow-up of participants and data collection have not yet been completed. Additional time is needed to
ensure study completion and to accomplish all study goals. Although ureteral stenting is routinely
performed after urological procedures for USD to mitigate peri-operative complications, stents cause
significant patient discomfort. The causal mechanisms are only partly understood. The STudy to
Enhance uNderstanding of sTent-associated Symptoms (STENTS) is a prospective observational
cohort study enrolling adolescents and adults undergoing ureteroscopic intervention for ureteral and/or
renal stones. Participants undergo detailed symptom assessment using validated questionnaires, a
psychosocial assessment, quantitative sensory testing for evaluation of pain sensitization, and detailed
collection of clinical and operative data. Biospecimens (blood and urine) are being collected for future
research. Recruitment to the STENTS study and follow-up of the participants are expected to be
completed on time. However, additional time and resources are needed for analysis of collected study
data. In Aim 1 of this application, the investigators will continue and complete participant enrollment for
the PUSH study, continue biospecimen collection for the NIDDK Repository, analyze the data, and
prepare and submit several planned manuscripts related to the study hypotheses. In Aim 2 of this
application, the investigators will analyze the data from the STENTS studies, interpret findings, and
disseminate findings through peer reviewed publications.

## Key facts

- **NIH application ID:** 10346196
- **Project number:** 2U01DK110994-06
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** NAIM M MAALOUF
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $655,872
- **Award type:** 2
- **Project period:** 2016-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10346196

## Citation

> US National Institutes of Health, RePORTER application 10346196, Fluid Therapy and Stent Management in Nephrolithiasis, USDRN extension (2U01DK110994-06). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10346196. Licensed CC0.

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